Kornimate/medical-research-clean huggingface dataset:
the effect of carvedilol vs endoscopic therapy in primary prophylaxis of high-risk esophageal gastric variceal bleeding

Conditions: Liver Cirrhosis; Esophageal and Gastric Varices

Summary: to compare the efficacy and safety of carvedilol and endoscopic therapy in primary prophylaxis of high-risk esophageal gastric variceal bleeding.

the study is a randomized controlled trial. patients randomly enter into two treatment groups: 1)the carvedilol group and 2)the endoscopy group. treatment allocation is by block randomization, with an two-to-one ratio for carvedilol and endoscopy. the results are concealed in opaque envelopes. the dose of carvedilol is titrated according to systolic arterial blood pressure (abpsys) and heart rate (hr). doses are increased every 7 days until abpsys is not less than 95 mm hg and hr is not less than 55 bpm. carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. patients receiving endoscopic therapy every 4 weeks until eradication of varices. patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.

Eligibility criteria:
inclusion criteria: * the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage * a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation exclusion criteria: * age greater than 80 years old or younger than 18 years old * non-cirrhotic portal hypertension * contraindications to nsbb including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on * abpsys less than 95 mmhg or hr less than 50 bpm * prior treatment for prevention of bleeding from egv * presence of spontaneous bacterial peritonitis or other severe infections * presence of hepatorenal syndrome * uncontrolled hepatic encephalopathy * presence of refractory ascites * pregnancy * presence of portosystemic shunt or portal cavernous transformation * refusal to participate in the study

Keywords: esophageal and gastric varices primary prophylaxis carvedilol endoscopy
back pain in patients with severe osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to compare the effectiveness of teriparatide versus therapies that decrease bone loss to prevent new or worsening back pain in patients with osteoporosis seen in clinical practice.

study b3d-cr-b013 is a prospective observational study to compare changes in back pain among patients treated with teriparatide versus those treated with antiresorptives (raloxifene, daily or weekly bisphosphonates).

Eligibility criteria:
inclusion criteria: * men and postmenopausal women who have a previous vertebral osteoporotic fracture that was sustained at least 6 weeks prior to joining the study. * patients who are free of severe or chronically disabling conditions other than osteoporosis. * patients who are not currently receiving and have not previously received teriparatide. * patients who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study. * patients, who in the opinion of the prescribing physician, are eligible to receive the intended treatment and comply with all the recommendations stated in the relevant product information. exclusion criteria: * are investigator site personnel directly affiliated with the study and/or their immediate families. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * are lilly employees (that is, employees, temporary contract workers, or designees responsible for conducting the study). immediate family of lilly employees may participate in lilly-sponsored clinical trials, but are not permitted to participate at a lilly facility. * patients who have any contraindications according to the relevant product information in the country in which they are being treated. * patients who are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
stk-012 monotherapy and in combination therapy in patients with solid tumors

Conditions: Advanced Solid Tumor; Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Malignant Melanoma; Renal Cell Carcinoma; Cervical Cancer; Microsatellite Instability High; Gastric Cancer; GastroEsophageal Cancer; Urothelial Carcinoma; Mismatch Repair Deficiency

Summary: this is a first-in-human, phase 1a/1b, multicenter, open-label, dose escalation study of stk-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors.

the phase 1a portion of the study is a dose escalation design to evaluate stk-012 as monotherapy and in combination therapy in patients with selected solid tumors. the phase 1b portion of the study includes dose expansions to evaluate stk-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (rp2d) in selected solid tumor types.

Eligibility criteria:
selected inclusion criteria: 1. participants enrolled to stk-012 monotherapy dose escalation and expansion and stk-012 + pembrolizumab combination dose escalation must have selected tumor types and progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment. 2. participants enrolled to stk-012 + pembrolizumab combination dose expansion must have selected tumor types and may not have received treatment for metastatic disease. 3. participants enrolled to stk-012 dose escalation combination treatment with pembrolizumab, pemetrexed and carboplatin must have nsclc and may not have received treatment for metastatic disease. 4. participants enrolled to stk-012 dose expansion combination treatment with pembrolizumab, pemetrexed and carboplatin must have pd-l1 negative nsclc and may not have received treatment for metastatic disease. selected exclusion criteria: 1. received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment. 2. received radiotherapy within 2 weeks of the first dose of study treatment. 3. received prior il-2-based or il-15-based cytokine therapy. 4. participants with nsclc may not have any known actionable genetic aberrations with approved therapies.
cbt for postpartum depression and infant emotion regulation

Conditions: Postpartum Depression

Summary: the primary objective of this study is to determine if online group cognitive behavioral therapy (cbt) for maternal postpartum depression (ppd) added to treatment as usual (tau) leads to greater improvements in infant emotion regulation (er) than maternal receipt of tau alone immediately post-treatment and 6 months later. this study will also aim to determine what mechanisms ppd treatment leads to changes in infant er.

a prospective, single-blind, parallel randomized controlled trial (1:1 ratio) that includes an experimental (receipt of a 9-week group cbt intervention delivered online plus tau) and control group (tau alone) to address our objectives. participants will have an epds score of 10 or more and an infant 3-12 months of age and be recruited from the community. the experimental group will receive a validated 9-week online group cognitive behavioral therapy (cbt) intervention on zoom plus tau. the control group will receive tau alone. in both groups, tau will consist of regular care from their family doctor, midwife, ob/gyn an/or any other types of care they may be accessing. the trial intervention consists of nine, 2-hour sessions occurring once per week. the first half of each session is devoted to core cbt content, including cognitive restructuring. the second half is devoted to group discussions co-led by participants on topics relevant to mothers with ppd (e.g., sleep, supports, role transitions). groups will be delivered by two trained psychologists, social workers, nurses, and/or psychiatrists. primary objective: determine if online group cognitive behavioural therapy (cbt) for maternal ppd added to treatment as usual (tau) lead to greater improvements in infant er than maternal receipt of tau alone immediately post-treatment and 6 months later. secondary objective: determine the putative mechanisms through which ppd treatment leads to changes in infant er.

Eligibility criteria:
inclusion criteria: * women 18 years of age or older * understand and speak english (so that they can participate in the cbt group and complete study measures) * live in ontario (the primary whcc catchment area) * have an epds score of 10 or more * meets diagnostic criteria for comorbid psychiatric conditions. * infants must be between 4-12 months old at enrollment. exclusion criteria: * bipolar disorder * a current psychotic disorder * substance or alcohol use disorder * antisocial or borderline personality disorder.
cefpodoxime vs ciprofloxacin for acute cystitis

Conditions: Urinary Tract Infection

Summary: urinary tract infection (uti) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. one of the most common antibiotics used to treat utis is ciprofloxacin, usually for a total of three days. however, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. an alternative antibiotic which is approved for use in utis is cefpodoxime. however, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of uti. the major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.

procedures subjects will undergo once they have read and signed the consent are: questions about their medical and sexual history and current symptoms of uti. they will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.they will be given a sheet to record symptoms at home. they will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy.follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Eligibility criteria:
inclusion criteria: * nonpregnant females in good general health with symptoms of acute cystitis exclusion criteria: * pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (\>2 weeks)exposure to an oral or parenteral antimicrobial; or history of uti in the previous 1 month

Keywords: uti
high dose dual therapy vs clarithromycin triple therapy for treatment naive h pylori infection in an urban population

Conditions: Helicobacter Pylori Infection

Summary: a phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high dose dual therapy vs standard triple therapy in a diverse, urban new york city population.

all patients, at least 18 years of age, with a chief complaint of dyspepsia and documented treatment-naïve hp infection diagnosed on ubt, esophagogastroduodenoscopy (egd) with hp biopsy, or sat were recruited for the study. dyspepsia was defined as persistent or recurrent abdominal pain for at least one month. all subjects who met inclusion criteria were randomly assigned by a computerized system to one of two treatment groups: standard triple therapy (stt) or high-dose dual therapy (hddt). after patient randomization, all potential side effects were discussed. education regarding the importance of adherence to complete the full 14 day regimen was provided. patients were provided an electronic prescription for the respective assigned regimen along with a medication log to self-report drug compliance. the patients were asked to record medication compliance and report any adverse events to research personnel. after completion of their assigned regimen, subjects were scheduled for a post-treatment visit, 4 weeks after completion of the study. during this period, patients were asked to abstain from taking ppi's to avoid false negative eradication testing. at the post-treatment visit, a medication log and empty pill bottles were brought in to ascertain compliance (defined as completing at least 90% of all prescribed medications).

Eligibility criteria:
inclusion criteria: * age 18 or older * treatment-naïve * clinical diagnosis of helicobacter pylori infection based on urea breath test, endoscopy or stool antigen test * subject willing to participate and able to provide informed consent. exclusion criteria: * prior helicobacter pylori treatment failure * antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis * pregnancy or breastfeeding * penicillin allergy * history of active or non-gastric malignancy * severe illness requiring hospitalization during treatment period * starting additional antibiotic while on treatment

Keywords: high-dose dual therapy standard triple therapy helicobacter pylori eradication clarithromycin resistance
efficacy of micro-pulse steroid therapy as induction therapy in patients with polymyalgia rheumatica

Conditions: Polymyalgia Rheumatica

Summary: the study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic nacl solution) immediately after diagnosis. both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of polymyalgia rheumatica exclusion criteria: * decompensated diabetes mellitus * decompensated arterial hypertension

Keywords: polymyalgia rheumatica
destiny breast respond her2-low europe

Conditions: Unresectable Breast Cancer; Metastatic Breast Cancer; HER2-low Expressing Breast Cancer

Summary: trastuzumab deruxtecan (t-dxd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

this non-interventional study will investigate the effectiveness witht-dxd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (adrs), and patient experience of t-dxd in patients with her2-low unresectable and/or metastatic breast cancer. patients will be treated according to the proposed indication statement in the summary of product characteristics (smpc). no drug product will be administered as part of this study. data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.

Eligibility criteria:
inclusion criteria: * adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mbc * documented her2-low status (ihc1+, ihc2+/ish-) * patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy * decision to newly initiate therapy of t-dxd or conventional chemotherapy according to the physicians choice per smpc * written and signed informed consent to participate in the study exclusion criteria: * pregnancy or breastfeeding * patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded. no specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the smpc.

Keywords: unresectable breast cancer metastatic breast cancer her2-low expressing breast cancer trastuzumab deruxtecan enhertu®
immune response to influenza vaccination

Conditions: Solid Organ Transplantation; Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the immune response to a routine influenza vaccination. influenza vaccination is given as part of routine standard of care in these individuals and is not part of the study protocol. the study will evaluate for a change in response to common antigens over time after influenza vaccination to determine if changes are related to the development of chronic rejection after solid-organ transplantation. we hypothesize that the influenza vaccine contributes to the alloreactivity of t cells verses common hla types in the donor pool.


Eligibility criteria:
inclusion criteria: * transplant recipients (lung or kidney) 18 years or older, more than 3 months after transplantation * transplant candidates (kidney) 18 years or older, to recieve influenza vaccination * healthy volunteers to receive influenza vaccination exclusion criteria: * under 18 years of age * pregnant * medical contraindication for vaccine * transplant recipients receiving acute rejection therapy within one month * healthy volunteers with autoimmune disease or medications to mediate immune function * receipt of live, attenuated influenza vaccine, instead of injectable vaccine

Keywords: lung transplantation kidney transplnatation chroinic kidney disease influenza
anti-tnf therapy and nerve conduction studies in ankylosing spondylitis

Conditions: Anti - TNF Therapy; Ankylosing Spondylitis; Neuropathy

Summary: patients with ankylosing spondylitis were divided into 2 groups as anti-tnf and conventional therapy according to the treatments they were using for the last 5 years. nerve conduction studies in the upper and lower extremities of the patients were compared.

demyelinating lesions in central nervous system after anti-tnf agents were reported previously. there are limited studies investigating the effects of anti-tnf treatments on the peripheral nervous system. the aim of this study is to investigate whether peripheral nerves are affected due to long-term use of anti-tnf agents. patients with a diagnosis of ankylosing spondylitis who received conventional or anti-tnf therapy for five years at istanbul physical therapy and rehabilitation training and research hospital were included in the study. the patients were divided into two groups as conventional group and anti-tnf group according to the treatment they received. all patients were evaluated in a single section. sociodemographic characteristics of the patients and bath ankylosing spondylitis disease activity index (basdai), bath ankylosing spondylitis functionality index (basfi) and bath ankylosing spondylitis metrology index (basmi) scores were recorded. median-ulnar motor and sensory conduction studies and tibial-peroneal motor and sural nerve sensory conduction studies were performed in both upper extremities of all patients. median, ulnar, and tibial nerve f-response studies were also performed.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ankylosing spondylitis * patients who have been using conventional therapy (non-steroidal anti-inflammatory drugs and/or salazopyrin) or anti-tnf therapy for more than 5 years. exclusion criteria: * patients with rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus ......) * patients with other systemic diseases that can lead to neuropathy * patients who have had a known neuropathy or have taken medication that can lead to neuropathy as a side effect * patients with pacemakers
ats 3f(r) aortic bioprosthesis model 1000 post approval study

Conditions: Heart Valve Diseases

Summary: the purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\</= 70 years of age) patients implanted with the model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

a multi-center non-randomized trial designed to obtain 606 patient years. each enrolled patient will be followed for a minimum of six (6) years. preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.

Eligibility criteria:
inclusion criteria: * patient is \</= 70 years of age and requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (the three remaining valves must be of native tissue). * patient is sufficiently ill to warrant replacement of his/her diseased natural or prosthetic valve (excluding the ats 3f aortic bioprosthesis, model 1000 bioprosthesis), based on standard cardiovascular diagnostic workups. * patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk, (i.e., likely to survive three years postoperatively). * patient is geographically stable and willing to return to the implant center for follow-up visits. * patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol. exclusion criteria: * patient is older than seventy (70) years of age. * patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 3 years. * patient is an intravenous drug and/or alcohol abuser. * female patient is pregnant (urine hcg test result positive), or lactating. * patient presents with active endocarditis. * patient presents with congenital bicuspid aortic anatomy. * this patient presents with abnormal aortic root geometry. * patient has chronic renal failure or is on renal dialysis. * patient has a previously implanted prosthetic valve that is not being replaced by a study valve. * patient requires mitral, tricuspid or pulmonic valve replacement. * patient presents with dilatation of the ascending aorta, marfan syndrome, ehlers-danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging. * patient is participating in concomitant research studies of investigational products. * patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.

Keywords: diseased heart valve, replacement, aortic, stentless